ABOUT ME

Key Qualifications

- Auditor (System Audit, Investigator Site Audit / Drugs & Medical Devices)

- Quality Assurance Manager

- Project Management of Clinical Trials (Phase I-IV)

- Monitoring (Phase I-IV and Medical Devices)

- Trainer (Regulatory/Ethical Requirements in Clinical Trials)

- Multi-lingual, fluent in German, English and Russian

Ella is a certified Quality Auditor and started her career in clinical research in a Phase I CRO in the Data Management Department in 1991. Subsequently as a CRA and senior CRA for several large CRO´s she gained massive experience in a wide range of therapeutic areas.

In 1998 Ella decided to start her own company and since then she has contracted with world class companies in both the pharmaceutical as well as the medical device sector in the role of: project manager, auditor and senior CRA. She conducted GCP trainings for Investigators, Study Teams, Monitors and CRO´s, SOP reviews and performed SOP writing. Ella has extensive experience in at least the following therapeutic areas:

Oncology, Immunology, Nutrition, Central Nervous System, Respiration, Volume Replacement, Organ Transplantation, Dermatology, Immunization, Gastroenterology, Narcotic Substances.

Ella has an excellent reputation as an auditor, with experience in CRO, investigator / site, system, TMF audits as well as remote audits in Russia and Ukraine.
Ella is multi-lingual and fluent in German, English and Russian.

Membership

since 2002 - GQMA (German Quality Management Association e. V. / DGGF e. V.)

since 2005 - RQA (Research Quality Association)

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